DE3204582A1 - Method of continuously producing plaster packs for transdermal administration of medicaments - Google Patents

Abstract

The method is intended for the continuous production of plaster packs for transdermal administration of medicaments. The pack comprises a two-layered cover enclosing the medicament and made of a material that is impermeable to the medicament, for example aluminium foil or the like, and furthermore comprises an intermediate layer which is arranged around the medicament in the outer edge region of the pack as well as a flexible film which is capable of adhering to the skin and covers the entire pack on one side. According to the method of the invention, the medicament is initially applied in metered portions at a distance from each other on a continuous strand of film which is not adhesive, or only weakly adhesive, on the application side and in respect of the medicament, and is covered and sealed with covering film sections appropriately pre-punched in the mould. All this is then covered with a flexible covering film capable of adhering to the skin, and the film is indirectly bonded to the strand of film carrying the medicament in the region of an intermediate film sealed to the strand of film. All films enclosing the medicament are then punched conjointly from the overall strand.

Description

Process for the continuous production of

Plaster packs for transdermal drug delivery ========================================= The invention relates to a method for continuous production of Pfalster packaging according to the preamble of the main claim.

Transdermal patches have been known for a long time, in particular for the treatment of rheumatic complaints, the drug being in the form of a zShpastßsen mass applied to a suitable, textile fabric and adhesive side is covered with a usually two-part, peelable cover sheet.

Such plasters, which are usually cut to a relatively large area, come in a letter envelope-like T (1st for sale. Sometimes such The plaster is still placed in a light and airtight sleeve to hold the medication Can be stored and kept effective for a longer period of time.

Meanwhile it has been found that you can also use other drugs that do not directly on skeletal parts or muakalpertien should act, can be administered tranadermally (i.e. through skin diffusion), i.e. with avoidance administration via the stomach or the anal area (suppositories), whichever Drug may affect these areas.

On the one hand, however, this type of drug application is one exact dosage in advance, but on the other hand also a special packaging design, who must ensure that the drug, if it is to have a long-term effect, only remains tightly covered in the direction of the skin and also before applications is tightly closed in the package. Such packaging is now have been developed and also have the desired therapeutic effect. Such.Verpackungen have a structure of the type mentioned and are then on the one hand ready for sale and immediately ready for application after division.

Since such packs consist of five components in total, the are to be connected to each other, and this in a relatively flat way, not heavily bulky form, these can not be easily and desirable continuously produce continuously; especially as one of the components must be able to adhere to the skin on one side, i.e. adhesive, but the adhesive itself of medication that has not been distributed in a gel that is no longer sticky after it has solidified more taken over. can be.

The invention is therefore based on the object of a method for continuous production of such packs to create the one hand in itself represent a storable structure and on the other hand after simple separation certain Components must be able to be applied to the skin without further aids.

This object is according to the invention with a method according to characterization of the main claim solved.

Advantageous further developments or practical embodiments result according to the subclaims 2 to 9, wherein the subclaims 2, 3 and 8, 9 all process variants represent applicable, advantageous developments, while the claims 4 to 7 mutually independent process variants of the basic principle represent as it is recorded in the identifier of the superordinate main claim.

These process steps and process variants can be carried out without further by using known elements and devices from packaging machine technology put into practice in terms of equipment, as well-known elements such as hole punches, sealing tools, Dosing filling stations, cover film stacking and transfer or application devices, Supply roll holder for the foil strips and the like, which are in the sense of the process steps Arrange on a suitably adapted machine frame and controlled by the work cycle and let them drive are readily available.

The following materials are used for the individual packaging components preferred in question: - A continuous aluminum foil that can be peeled off the roll, if necessary with a coating on the application side that prevents the drug from sticking.

- Also Al-Folis for the pre-cut cover foil, at least that is provided with a sealing wax layer in the sealing end area.

- For the intermediate film of silicone paper, which is on the one hand with the continuous Al foil is sealable.

- A thin, elastic, foam-rubber-like film for the skin-adhesive film Foil that has an adhesive adhesive on one side.

Deep-drawing into continuous aluminum foil becomes flat cells therefore preferably carried out within the framework of the procedures, because then the applied in the form of a relatively large, thick drop containing the drug, gel-like mass in the edge areas defined in the cell with slight pressure application distributed and solidified in this form defined. This prevents the gel mass flows into the edge areas of the packaging to be sealed later, which is a flawless one Sealing would oppose it.

Depending on the width of the aluminum foil tape, the dosage of the drug batches is increased arranged in a row one behind the other or several rows next to one another, namely with sufficient distances to each other, so that sufficiently large edge areas for the sealing and gluing of the packaging components remain available.

With the application or metering of the gel-like medicament mass it is to be understood that these froze both in the psst # een, but also already in the shape of a wafer State of the Al foil can be added.

However, it is preferred to meter in pasty, not yet solidified State, since this is easier to accomplish in terms of apparatus and no additional measures must be taken (especially if the Al foil is not deep-drawn, flat Has wells) to prevent slipping of the medicament wafer (for example, from a solidified gel strands could be punched out) during the further course of the process to prevent.

Apart from the process variant according to claim 6, the intermediate layer pre-punched from silicone paper with a slightly larger hole diameter compared to the diameter of the pre-cut Al cover foil, i.e. in such a The silicone paper is prepackaged in the form of a ring.

The finished individual packs are divided and thus exposed of the drug readily accessible. To facilitate such a breakdown the aluminum foil is expediently provided with a cut-off tab in the edge area Mistake. The strength of the sealing and adhesive areas are coordinated in such a way that that after division two parts of the pack are created.

The part that can be applied to the skin consists of the elastic, foam-rubber-like Adhesive film on which centrically the pre-stamped aluminum foil section sits, which has a smaller diameter than the Klebefolis and on which, in diameter in turn smaller, the solidified gel mass containing the drug sits then, after application to the skin, under the influence of the hearing temperature slowly dissolves, releasing the drug for diffusion into the skin, whereby neither the gel-Masee nor the medicament is covered by the Al cover foil can escape to the other side. A side exit is through the wide sticking of the adhesive film prevents.

The other part that is pulled off consists of the Al foil with the deep gaz Cup and from the sealed-on silicone piercing ring.

The method according to the invention and its various variants are shown below with reference to the graphic representation of exemplary embodiments explained in more detail.

It shows schematically Fig. 1 in plan view of the to be applied to the skin Part of the packaging; 2 shows a plan view of the disposable part of the packaging that is to be pulled off; Fig. 3 shows a section through the entire package, greatly enlarged, and FIGS. 4-8 schematically the different arrangements of the necessary processing operations for the different Procedures.

According to FIG. 4, a roller is on the left side of the machine frame 1 from Al-Folis 1 'and a roll 2 from the foam rubber-like adhesive film arranged, at the same time, to prevent sticking, a silicone paper film as Liner 3 is wound.

After passing a dancer roller guide 4, the aluminum foil 1 is tuned provided in a deep-drawing station 5 with the flat cups 6, in which then in the Filling station 7, the pasty gel mass is metered in. Be in the covering station 8 from stacking magazines 9, the pre-cut Al cover films lo removed and on the still thick drop-shaped measure put on and lightly pressed, whereby the still deformable gel mass 15 evenly distributed in the relevant well and largely fills this out.

The next station 11 is a combined sealing and punching station, which are run through by the silicone plywood in the upper area for the purpose of punching holes, after directed downwards and hole covering the same as the deep-drawn and filled cups 6 are brought together with the Al foil 1 and in the lower part this station 11 is sealed, i.e. the two Al components are sealed together and the silicone paper film 3 is sealed onto the Al film 1 '.

Station 12 is a coding station of no further interest here, behind which the adhesive film 2 'after the silicone paper film has been peeled off by means of a peel-off device ste 13 is placed on the filled strand on the adhesive side.

This Besamtatrang then becomes in another punching station 14 punched out the individual packs in a circular shape and a cardboard packaging (not shown) fed.

As can be seen, the silicone paper film 3 is opposed here returned to the actual direction of passage 3, which occurred at the beginning of the passage requires that a correspondingly long piece of silicone paper film 3 first run up or an adhesive film section behind the separating strip 13 are first cut off can.

Corresponding stations or film components are shown in FIG corresponding reference symbols.

The procedure here is as follows: The unperforated silicone paper film 3 is on a special role that is used in the preproduction of a run has arisen by peeling off the adhesive film 2 '. In the punching station 11 'is the silicone paper film 3 is perforated and then runs as a perforated film 3 'with the aluminum film 1 'together in a sealing station 11, after which the Al foil 1' is concentric to the hole in the silicone paper film 3 'in the deep-drawing station 5 with flat cells 6 is provided. In the station 7 is filled and then the Al cover foil sections lo applied, which are then sealed with the Al-Folis 1 '. Afterward the application of the adhesive film 2 and the punching out of the individual pegs are carried out in the punching station 14.

6 shows a further variant of the method. This is where the Al foil 1 'first deep-drawn, filled at 7, covered in 8, and both foils are sealed together in 11. The silicone paper film 3 runs into the punch 11 'and is fed to the filled and covered Al foil 1'. After being sealed the perforated silicone paper film 3 'in the sealing station 11t is applied the adhesive film 2, after this, as described, from the silicone paper was released. In 14 the individual packs are punched out again.

The method according to FIG. 7 largely corresponds to that according to FIG. 8, with the difference is that here the drug and the sel-mass containing it solidify and applied to the Al foil 1 'in a preformed manner.

The Al cover film section lo is either preformed like a cup puffed up or molded and sealed after simply laying it on. Then take place again, one after the other, the feed of the pre-punched silicone paper film and its Sealing and finally the application of the adhesive film 2 and the Sesemteus punch of the single packs.

In the procedure of FIG. 8, the silicone paper film is perforated 3 can be dispensed with, since this, laminated with the Al foil 1 ', together with this in the Machine runs in, i.e. the gel mass with the drug is applied here on the silicone paper 3. The cover film section lo is, if necessary, cup-like preformed, applied and sealed. The adhesive film is then applied 2 and the punching out of the individual packs.

Individual processing states of the foils are shown in FIGS. 9-11, as they result in the method according to FIG.

After pulling apart or dividing the pack shown in FIG. 3 represent the pack parts in an inside plan view in the sense of FIGS. 1, 2 which are to be considered in connection with the sectional view according to FIG. 3, to make it clear that both parts consist of only two components, namely 2, lo and 1 ', 3' exist.

In Fig. 2 is also a possible form of an opening aid in the form a tear-off strip 16 indicated.

Claims (9)

Claims: 1. Process for the continuous production of Plaster packaging for the transdermal administration of drugs, whereby the pack from a two-layer hall enclosing the drug from fnr the drug impermeable material such as Al foil od. Like. Is and further from one arranged around the medication in the outer edge area of the pack Intermediate layer and made of a skin-adhesive that covers the whole package on one side elastic film, d u r h e k e n n n z e i c h n-e t that the drug first in dosed amounts in portions with a distance to each other on a continuous and on the application side and with respect to the drug not or only weakly adhesive Film strand applied and with corresponding pre-cut cover film sections in the form covered and sealed, the whole thing with a skin-adhesive, elastic Cover film covered and this with the film strand, which carries the drug, in the Get one with that Film strand sealed the intermediate film indirectly glued and then all the medicament enclosing foils together from the Entire strand to be danced out. 2. The method according to claim 1, d a d u r c h g e k e n nz e i c h n e t that the one envelope film with flat, deep-drawn ones before the drug is added Cup is provided. 3. The method according to claim 1 and / or 2, d a d u r c h g e k e n n notices that the intermediate film is the one peeled off from the skin-adhesive film Cover sheet is used. 4. The method according to any one of claims 1 to 3, d a d u r c h g e k It is noted that on the one envelope film in the form of a film tape the Drug dosed in single doses and with a spacing from one another and the single doses be covered with the other pre-cut envelope film that the intermediate layer and the elastic film, which is skin-adhesive on one side, is conveyed together in the form of a tape and are separated before being connected to the enveloping foils carrying the medicament, the one detached, not adhesive interlayer films perforated and brought together with the envelope film carrying the drug and these three components are sealed or glued together or separately and that then the separated, unperforated and skin-adhesive film is applied on the adhesive side and then all of the medicament-enclosing foils together from the total string be punched out. 5. The method according to any one of claims 1 to 3, d a d u r c h g e k It is noted that the medicament is dosed onto one of the foil tape envelopes, the dosed medicament covered with the punched envelope and both Wrapping foils are sealed around the drug, after which the pre-punched liner fed and sealed to one of the foil tape envelopes, then after one has been withdrawn Cover film the skin-adhesive film is applied and the entire strand individual plaster packs were euagecut. 6. The method according to any one of claims 1 to 3, d a d u r c h g e k It is noted that the drug is on the one foil tape laminated intermediate layer dosed and with the other pre-cut Cover foil and seal all three foils around the medication, after which the elastic film capable of being adhered to the skin is applied with its adhesive surface and the individual packs are punched out from the entire strand. 7. The method according to any one of claims 1 to 3, d a d u r c h g e k It is noted that the intermediate film is prepunched with one of the wrapping films added and then the drug in the appropriate amount on the of the Intermediate film uncovered area of the enveloping film and dosed with the pre-punched Covering foil covered and this pre-cut covering foil with the other covering foil is sealed, after which the skin-adhesive film is applied after a cover film has been removed and then the individual plaster packs are punched out of the entire strand. 8. The method according to any one of claims 1 to 7, d a d u r c h g e k It is noted that on the foil tape on which the drug is dosed, an opening aid is cut in the area of the later packaging edge. 9. The method according to any one of claims 1 to 8, d a d u r c h g e k It is clear that the entire packaging from the packaging strand is circular is danced out.